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Une similitude entre normes de sécurité de produits entraîne-t-elle une similitude de niveaux de sécurité du consommateur ? En 2007, plus de 19 millions de jouets ont fait l'objet d'un rappel à l'échelle mondiale parce qu'ils n'étaient pas conformes aux normes de sécurité applicables. À la suite de ces rappels, les États-Unis et l'Union européenne (U.E.) ont chacun adopté une nouvelle réglementation sur les produits destinés aux enfants : il s'agit, respectivement, de la loi sur l'amélioration de la sécurité des produits de consommation ( Consumer Product Safety Improvement Act ) de 2008 et de la directive relative à la sécurité des jouets de 2009. Toutefois, bien que leurs formulations soient proches, les normes de sécurité des jouets – résultat de ces législations –, comme ISO 8124 (ISO), ASTM F963 (États-Unis) et EN 71 (U.E.), ne produisent pas les mêmes effets. Après avoir analysé une série de données sur les systèmes d'évaluation de la conformité de l'U.E. et des États-Unis destinés à évaluer la sécurité des jouets fabriqués en Chine, nous avons constaté que le total pondéré des rappels de produits non conformes était dix à vingt fois plus élevé dans l'U.E. qu'aux États-Unis. Il semblerait donc que les différences de modalités de mise en œuvre des normes mondiales entraînent une exposition des consommateurs aux produits dangereux plus ou moins importante selon les régions. Remarques à l'intention des praticiens Les responsables publics ne doivent pas considérer les normes internationales comme l'alpha et l'oméga en matière de sécurité. Les mécanismes visant à vérifier la conformité des produits aux normes établies sont aussi importants que les normes elles-mêmes et peuvent avoir des incidences non négligeables sur le plan économique comme sur celui de la sécurité. De nombreux facteurs guident le choix d'un système d'évaluation de la conformité d'un produit ou d'un marché donnés, notamment le goût du risque, les institutions et les pratiques politiques et les moyens, plus ou moins importants, dont dispose l'administration au niveau national. Il convient donc de prendre en considération l'ensemble de ces facteurs lorsque l'on analyse un tel système.

Do similar standards of product safety lead to similar levels of consumer safety? In 2007, more than 19 million toys worldwide were recalled for violations of applicable safety standards. Following these recalls, both the EU and the US instituted new policies governing children's products: the US Consumer Product Safety Improvement Act of 2008 (CPSIA) and EU 2009 Toy Safety Directive. The relevant toy safety standards that emerged from this legislation, such as ISO (ISO 8124), US (ASTM F963), and EU (EN 71) standards are comparable in terms of their language but not their results. Using a data set profiling implementation of EU and US conformity assessment systems for determination of product safety for toys manufactured in China, we find that weighted recall totals for violative products are between 10 and 20 times higher in the EU than the US. This suggests that differences in the implementation of global standards result in more unsafe products initially reaching consumers in some locations. Points for practitioners Government officials should avoid assuming that safety begins and ends with international standards. The process for verifying that products meet established standards is as important as the standards themselves, and it can have significant economic and safety impacts The choice of conformity assessment system for a given product or market is driven by many considerations, including appetite for risk, political institutions and practice, and variations in national-level administrative capacity. Discussions on the merits of any conformity assessment system for a given market, or product, should incorporate all of these factors.

BACKGROUND: The use of antiretroviral therapy has reduced morbidity and mortality associated with HIV infection primarily due to the reduction of AIDS-related events. Although guidelines have aimed to standardize preventive care, disparities in prevention of cardiovascular disease remain prevalent across multiple cohorts. METHODS: The US Military HIV Natural History Study is an open cohort of Department of Defense beneficiaries. We included subjects aged 21–75 whose most recent study visit was between October 2015 and September 2016 and conducted a retrospective cross-sectional analysis of established cardiovascular disease risk factors and statin use. To determine statin eligibility we used the American College of Cardiology/American Heart Association 2013 atherosclerotic cardiovascular disease management guidelines and included subjects who had all necessary data elements for analysis. RESULTS: The participants (n = 1223) were predominantly middle-aged (median 47 years, Interquartile Range [IQR] 33–55), male (95%), and were racially diverse (46% African-American, 16% Hispanic/other). The rate of tobacco use was 16%, diabetes was 11%, and 36% had hypertension. In total, 486 (40%) patients met criteria for statin therapy, with 17% of those being for secondary prevention. As of their last visit, 52 (4%) had a detectable HIV viral load. Statins were prescribed to only 302 (62%) of those with an indication, with lower prescription rates in African Americans (52%) and Hispanics (58%) than Caucasians (73%). Average blood pressure, rates of tobacco use, and prevalence of diabetes were equal between the African American and Caucasian groups. CONCLUSION: We found significant racial disparities in both primary and secondary cardiovascular disease mitigation within the military healthcare system. Previous studies have found similar racial differences attributed to socioeconomic factors and higher rates of intravenous drug use. As active duty service members have a stable income, open access to healthcare, and low rates of ...

BACKGROUND: Early recognition of high-risk patients with coronavirus disease 2019 (COVID-19) may improve outcomes. Although many predictive scoring systems exist, their complexity may limit utility in COVID-19. We assessed the prognostic performance of the National Early Warning Score (NEWS) and an age-based modification (NEWS+age) among hospitalized COVID-19 patients enrolled in a prospective, multicenter US Military Health System (MHS) observational cohort study. METHODS: Hospitalized adults with confirmed COVID-19 not requiring invasive mechanical ventilation at admission and with a baseline NEWS were included. We analyzed each scoring system's ability to predict key clinical outcomes, including progression to invasive ventilation or death, stratified by baseline severity (low [0–3], medium [4–6], and high [≥7]). RESULTS: Among 184 included participants, those with low baseline NEWS had significantly shorter hospitalizations (P < .01) and lower maximum illness severity (P < .001). Most (80.2%) of low NEWS vs 15.8% of high NEWS participants required no or at most low-flow oxygen supplementation. Low NEWS (≤3) had a negative predictive value of 97.2% for progression to invasive ventilation or death; a high NEWS (≥7) had high specificity (93.1%) but low positive predictive value (42.1%) for such progression. NEWS+age performed similarly to NEWS at predicting invasive ventilation or death (NEWS+age: area under the receiver operating characteristics curve [AUROC], 0.69; 95% CI, 0.65–0.73; NEWS: AUROC, 0.70; 95% CI, 0.66–0.75). CONCLUSIONS: NEWS and NEWS+age showed similar test characteristics in an MHS COVID-19 cohort. Notably, low baseline scores had an excellent negative predictive value. Given their easy applicability, these scoring systems may be useful in resource-limited settings to identify COVID-19 patients who are unlikely to progress to critical illness.

BACKGROUND: While the majority of illness due to COVID-19 does not require hospitalization, little has been described about the host inflammatory response in the ambulatory setting. Differences in the levels of inflammatory signaling proteins between outpatient and hospitalized populations could identify key maladaptive immune responses during COVID-19. METHODS: Samples were collected from 76 participants (41% female, mean 46.8 years of age) enrolled at five military treatment facilities between March 20, 2020 and June 17, 2020 in an ongoing prospective COVID-19 cohort. This analysis was restricted to those with positive SARS-CoV-2 (severe acute respiratory syndrome–coronavirus 2) RT-PCR testing and included hospitalized (N=29; 10 requiring an ICU stay) and non-hospitalized (N=43) participants. Severity markers (IL6, D-dimer, procalcitonin, ferritin, ICAM-1, IL5, lipocalin, RAGE, TNFR, VEGFA, IFNγ, IL1β) were measured in plasma (mg/dL) using the Ella immunoassay and natural log transformed. Univariate negative binomial regression was performed to determine relative risk of hospitalization. Using the full marker panel, we performed a Principal Component Analysis (PCA) to determine directions of maximal variance in the data. Pearson's correlation coefficient was determined between analytes and each axis. RESULTS: Participants requiring ambulatory-, hospital-, and ICU-level care had samples collected at 44.0 (IQR: 35.0–51.0), 40.0 (13.0–51.0), and 47.5 (21.0–54.0) days, respectively. Higher unadjusted levels of IL6, D-dimer, procalcitonin, or ferritin were each associated with hospitalization (Table 1). The PCA showed a separation along axes between level of care and duration of symptoms (Fig 1). While significant correlations were noted with a number of biomarkers, PC1 most correlated with TNFR1 (r=0.88) and PC2 most correlated with IL6Ra (r=0.95). PC1 axis variation accounted for 36.5% of variance and the PC2 axis accounted for 20.0% of variance. Figure 1. Principal Component Analysis (PCA) of biomarkers by level ...

BACKGROUND: We evaluated clinical outcomes, functional burden, and complications 1 month after coronavirus disease 2019 (COVID-19) infection in a prospective US Military Health System (MHS) cohort of active duty, retiree, and dependent populations using serial patient-reported outcome surveys and electronic medical record (EMR) review. METHODS: MHS beneficiaries presenting at 9 sites across the United States with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, a COVID-19-like illness, or a high-risk SARS-CoV-2 exposure were eligible for enrollment. Medical history and clinical outcomes were collected through structured interviews and International Classification of Diseases–based EMR review. Risk factors associated with hospitalization were determined by multivariate logistic regression. RESULTS: A total of 1202 participants were enrolled. There were 1070 laboratory-confirmed SARS-CoV-2 cases and 132 SARS-CoV-2-negative participants. In the first month post–symptom onset among the SARS-CoV-2-positive cases, there were 212 hospitalizations, 80% requiring oxygen, 20 ICU admissions, and 10 deaths. Risk factors for COVID-19-associated hospitalization included race (increased for Asian, Black, and Hispanic compared with non-Hispanic White), age (age 45–64 and 65+ compared with <45), and obesity (BMI≥30 compared with BMI<30). Over 2% of survey respondents reported the need for supplemental oxygen, and 31% had not returned to normal daily activities at 1 month post–symptom onset. CONCLUSIONS: Older age, reporting Asian, Black, or Hispanic race/ethnicity, and obesity are associated with SARS-CoV-2 hospitalization. A proportion of acute SARS-CoV-2 infections require long-term oxygen therapy; the impact of SARS-CoV-2 infection on short-term functional status was substantial. A significant number of MHS beneficiaries had not yet returned to normal activities by 1 month.